ACL ELITE- Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinol
Summary
The FDA issued a Class II for ACL ELITE- Analyzer designed specifically for clinical use in the hemostasis lab by Instrumentation Laboratory. Reason: Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the ACL Elite/Elite Pro instruments.
Details
Source
Device Recall
External ID
Z-1304-2023
Action Date
2023-04-05
Status
Ongoing
Category
device
Product Description
ACL ELITE- Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0000880311
Lot/Code Info: UDI: 08426950453017 Serial Numbers 23012282 and Prior
Quantity Affected: 358 units US; 558 units OUS
Reason for Recall
Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the ACL Elite/Elite Pro instruments
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Albania, Algeria, Australia, Austria, Azerbaijan, Belarus, Belgium, Brazil, Bulgaria, Cape Verde, China, Colombia, Czech Republic, Egypt, Falkland Islands, Finland, France, Georgia, Germany, Ghana, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Italy, Japan, Jordan, Kazakhstan, Kenya, Kossovo, Latvia, Lebanon, Lithuania, Malawi, Malaysia, Mexico, Philippines, Poland, Romania, Russian Fed., Saudi Arabia, Serbia, South Africa, South Korea, Spain, Sri Lanka, Switzerland, Taiwan, Thailand, Ukraine, United Kingdom, Uruguay, Utd.Arab Emir., Vietnam, Zimbabwe.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-02-03
Company
Bedford, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 119 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Instrumentation Laboratory has 39 FDA actions in our database, including 38 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Instrumentation Laboratory) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Instrumentation Laboratory have FDA actions?
Instrumentation Laboratory has 39 FDA actions in our database, including 38 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1304-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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